Everly Health

Director, Regulatory and Quality Assurance

Everly Health

full-time

Posted on:

Origin:  • 🇺🇸 United States • Illinois

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Salary

💰 $160,000 - $190,000 per year

Job Level

Lead

Tech Stack

Cloud

About the role

  • Provide strategic leadership and oversight of Everly Health’s enterprise Quality Management System (QMS) and regulatory affairs operations.
  • Ensure quality and regulatory compliance across FDA-regulated manufacturing operations, CLIA-certified moderate complexity laboratory, and other lines of business.
  • Lead the preparation and submission of regulatory filings (e.g., FDA, NYS, CMS, CAP), including premarket notifications, amendments, and renewals.
  • Interpret and apply complex and evolving U.S. regulations and guidance impacting IVDs, SaMD, telehealth, and consumer wellness products.
  • Advise executive leadership on regulatory strategy, including changes affecting at-home diagnostics, software development, and kit configuration.
  • Serve as a liaison with regulatory bodies and support audit/inspection readiness and responses.
  • Develop, lead, and continuously improve the enterprise Quality Management System to ensure compliance with QSR, ISO 13485, and applicable client-imposed compliance frameworks.
  • Serve as Management Representative for regulatory inspections, internal audits, and customer audits.Oversee enterprise-level risk management processes, including hazard analysis, FMEA, and CAPA systems.
  • Establish and monitor key quality and compliance KPIs; use data-driven insights to inform risk mitigation and continuous improvement initiatives.
  • Partner with Product, Technology, Legal, and Operations to embed regulatory and quality by design principles early in the product lifecycle, including requirements for SaMD under IEC 62304 and CLIA/NYS validation standards.
  • Collaborate with Engineering and Manufacturing teams to ensure digital and physical product quality standards are met and sustained.
  • Guide quality oversight for third-party service providers, including contract manufacturers, labs, and fulfillment partners.
  • Lead, coach, and mentor a team of regulatory and quality professionals.
  • Foster a high-performing, inclusive, and psychologically safe team environment.

Requirements

  • Bachelor's degree in Life Sciences,Regulatory Affairs, or related field (advanced degree a plus)
  • Minimum 7-10 years of experience in regulatory affairs and/or quality assurance within diagnostics, medical devices, or digital health sectors.
  • Expertise in 21 CFR Part 820, ISO 13485, 14971, and 62304
  • Expertise in FDA regulatory submissions (510(k), Convenience Kit, EUA, etc.)
  • Expertise in Risk management tools (FMEA, fault tree, root cause analysis, etc.)
  • Experience in managing regulatory and quality oversight for both physical product manufacturing and moderate complexity laboratory
  • Proven success leading audits/inspections and responding to agency inquiries
  • Exceptional cross-functional communication and influencing skills
  • Demonstrated success managing and mentoring high-performing teams